Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease（RESTEP Study）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053726
• Other study ID #: PINS-025
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2017
• Last updated: March 13, 2018
• Start date: August 18, 2017
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Beijing Pins Medical Co., Ltd
• Contact: Fumin Jia
• Phone: 010-60736388
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the VFS paradigm the stimulation frequency was set to alternate between high and low frequencies, where the frequency of stimulation or frequency combinations can be changed instantaneously according to damage of the moment rhythms. Variable frequency stimulation is a novel dynamic therapy which breaks through the existing single high-frequency stimulation paradigms. It is the world's first VFS therapy for the brain.

Description:

In advanced stages of PD, motor symptoms and dyskinesia are effectively treated by deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) . Traditionally, in this procedure, stimulation is set to a constant frequency electrical stimulation with the physician programming the parameters of stimulation frequency, pulse width and amplitude, and stimulated patients' brain nuclei with single frequency, single pulse width and single amplitude of the electric stimulation. Indeed, high frequency stimulation (HFS) of the STN provides consistent, long-term improvement of the cardinal signs of PD . However, the treatment effects of HFS on the axial symptoms of PD, specifically FOG can be poor often causing further impairment. While this can be alleviated by using relatively low frequency stimulation (LFS) , major concerns in the clinical application of LFS exist in regards to its duration of therapeutic benefit. Previous studies have shown that LFS of the STN improves the axial motor signs in some PD patients, but a loss of therapeutic efficacy is seen in the short term. Thereafter, patients may present increased tremor, rigidity and bradykinesia, which is often intolerable outweighing the initial benefits of LFS therapy for FOG. As such, a suitable treatment strategy for FOG remains to be established.

Based on previous findings on the relationships between stimulation frequency and movement rhythm regulation in the human body, The National Engineering Laboratory for Neuromodulation, Tsinghua University, proposes a method of variable frequency stimulation (VFS) for aiding movement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients With Idiopathic Parkinson's Disease.

2. =18 years,both male and female

3. Patients who under deep brain stimulation

4. MMSE score =24

5. H-Y=2.0 under the medicine off/ constant frequency stimulation state

6. The 14 item of UPDRS-II score =1

7. The 15 item of UPDRS-II score =2

8. Subjects had an ability to walk = 10 meters independently under the medicine off/ constant frequency stimulation state

Exclusion Criteria:

1. Pregnant women or breastfeeding mothers, or woman who cannot take effective measures to prevent pregnancy.

2. Presence of other diseases affecting walking distance, such as joint disease in lower body, spinal disease, neuropathy, serious heart or lung disease.

3. Diseases seriously affecting health and life, such as tumour, serious liver or kidney diseases etc.

4. Patients with epilepsy etc.

5. Presence of mental disorders or dementia.

6. Patients or their families who cannot comprehend the therapy or patients who are unable to give informed consent voluntarily.

7. Patients whom cannot cooperate well with follow-up requirements.

8. Patients excluded based on the researchers judgement for participation in the clinical trial.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Variable Frequency Stimulation
vary the frequency of the stimulation parameter

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	General Hospital of PLA	Beijing
China	Peking Union Medical College Hospital	Beijing
China	The First Affiliated Hospital of Dalian Medical University	Dalian
China	Nanjing Brain Hospital Affiliated to Nanjing Medical University	Nanjing
China	Changhai Hospital of Shanghai	Shanghai
China	Huashan hospital, Fudan university	Shanghai
China	The General Hospital of Shenyang Military	Shenyang
China	Second People's Hospital of Shenzhen	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stand-Walk-Sit	The total time of patients who complete the Stand-Walk-Sit task	at 3 months compare to baseline
Secondary	United Parkinson's Disease Rate Scale scores		at 3?6 months compare to baseline
Secondary	The39-item Parkinson's Disease Questionnaire (PDQ-39) scores		at 3?6 months compare to baseline
Secondary	The Freezing of Gait Questionnaire (FOG-Q) scores		at 3?6 months compare to baseline
Secondary	Gait and Falls Questionnaire (GFQ) scores		at 3?6 months compare to baseline